MEDICINES SHORTAGES PGEU GPUE. John Chave - Secretary general. Pharmaceutical Group of European Union Groupement Pharmaceutique de l Union Européenne
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1 MEDICINES SHORTAGES John Chave - Secretary general
2 Members: Professional Bodies & Pharmacists Associations 2013: 32 Countries Austria Belgium Bulgaria Bosnia Herzegovina Cyprus Czech Rep Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom Croatia FYR Macedonia Norway Serbia Switzerland Turkey
3 PGEU Survey 2013 All respondents reported medicine shortages, although severity of shortages varies. Many reported that the situation had got worse in last 12 months. Pharmacists spend 3-15 hours/month sourcing medicines in short supply. Patients are affected directly through unavailability but as well indirectly when their pharmacist has to spend time sourcing medicines rather than providing services.
4 PGEU Survey 2013 Medicines affected include: Generic medicines such as Fenopine (ibuprofen), Pantoprazol MER (pantoprazol), Venlafaxin HEX (venlafaxine), etc. Branded medicines such as Cymbalta (duloxetinum), Symbicort Turbohaler (budesonide - formoterol), etc.
5 Fundamental Causes Causes are multifactorial and to some extent unknown, however, two fundamental factors: 1. Production Constraints (e.g. supply chain, regulatory, manufacturing difficulties, insufficient capacity); 2. Reduced incentive to supply (e.g. insufficient margin (opportunity cost of supply); fear of parallel export.
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8 The Dutch Generic Tendering System The effects of tendering on prices in the Netherlands, Top 10 packs by sales, May-June 2008 Pharmaceutical Product Preferred supplier Pharmacy purchase price ( ) Change May 2008 June Omeprazole tablets/capsules, 20 mg Ratiopharm % 2. Alendroninezuur tablets, 70 mg Centrafarm % 3. Omeprazole tablets/capsules, 40 mg Centrafarm % 4. Paroxetine tablets, 20 mg Ratiopharm % 5. Simvastatin tablets, 40 mg Actavis % 6. Pravastatin tablets, 40 mg Focus Farma % 7. Simvastatin tablets, 20 mg Ratiopharm % 8. Tamsulozine tablets/capsules, 0.4 mg Centrafarm % 9. Amlodipine tablets, 5 mg Ratiopharm % 10. Citalopram tablets, 20 mg Ratiopharm % Source: Stichting Farmaceutische Kengetallen (SFK), quoted in Kanavos, Seeley and Vandoros, 2009 Since the first wave of tenders the Dutch generics market decreased 66% - Off Patent prices fall on average 85%
9 Consumer Price Index (NHS market in the outpatient sector) Average Price Jan-10 Average price Mar-13 16,84 Brands 15,07 16,31 Generics 6,80 Source: hmr / CEFAR Note: Base 100 = 2009
10 The Issue of Parallel Distribution A number of EU countries are currently considering export bans these are bound the be tested in the courts; More research needed to establish if PD is major contributory factor in exporting markets; The extent to which manufacturer behaviour induces shortages in exporting markets is disputed.
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12 PGEU Survey 2013 Pharmacy associations, like IPU in Ireland or KNMP in the Netherlands produce a lists of medicines in short supply every month to assist pharmacists. Some regulators set up websites to inform public and professionals about unavailability of medicines in their territory (Belgium, Italy, Lithuania, etc.) Information on these lists is provided by the manufacturers on voluntary basis.
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17 What shall we do? There must be improved communication throughout the supply chain on the likelihood, causes and extent of shortages; Governments need to factor potential supply problems into pricing/competition decisions; In the immediate short term, the certification of imported Active Pharmaceutical Ingredients by the EU Commission is an urgent priority.
18 THANK YOU
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